{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bethlehem",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA022462"
        ],
        "brand_name": [
          "GABLOFEN"
        ],
        "generic_name": [
          "BACLOFEN INJECTION"
        ],
        "manufacturer_name": [
          "Piramal Critical Care Inc"
        ],
        "product_ndc": [
          "66794-151",
          "66794-155",
          "66794-156",
          "66794-157"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRATHECAL"
        ],
        "substance_name": [
          "BACLOFEN"
        ],
        "rxcui": [
          "308517",
          "1047437",
          "1047440",
          "1047444",
          "1300890",
          "1301627",
          "1369783",
          "1369784",
          "1369787",
          "1369788",
          "1369791",
          "1369792",
          "1666613",
          "1666615"
        ],
        "spl_id": [
          "5135dfce-e3c4-a382-e063-6394a90a4875"
        ],
        "spl_set_id": [
          "00d3e846-dd92-448d-9ab8-6a07be823cc1"
        ],
        "package_ndc": [
          "66794-151-01",
          "66794-155-01",
          "66794-155-02",
          "66794-156-01",
          "66794-156-02",
          "66794-157-01",
          "66794-157-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0366794157024",
          "0366794155020",
          "0366794156027"
        ],
        "nui": [
          "N0000000196",
          "N0000000116",
          "N0000175759"
        ],
        "pharm_class_moa": [
          "GABA A Agonists [MoA]",
          "GABA B Agonists [MoA]"
        ],
        "pharm_class_epc": [
          "gamma-Aminobutyric Acid-ergic Agonist [EPC]"
        ],
        "unii": [
          "H789N3FKE8"
        ]
      },
      "product_type": "Drugs",
      "event_id": "83280",
      "recalling_firm": "Piramal Critical Care, Inc.",
      "address_1": "3950 Schelden Cir",
      "address_2": "N/A",
      "postal_code": "18017-8936",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-1742-2019",
      "product_description": "Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-01",
      "product_quantity": "Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes)",
      "reason_for_recall": "Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.",
      "recall_initiation_date": "20190708",
      "center_classification_date": "20190813",
      "termination_date": "20210309",
      "report_date": "20190807",
      "code_info": "Lot #: 2155-111, 2155-111A, Exp 6/20"
    }
  ]
}